This study helped researchers learn if a medicine called SHP465 could help adults with ADHD have fewer symptoms and/or less severe symptoms.

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1 Summary of Clinical Trial Results Thank you! Thank you to those people who took part in this clinical study. This study helped researchers learn if a medicine called SHP465 could help adults with ADHD have fewer symptoms and/or less severe symptoms. Why was this study done? Researchers wanted to learn if a new medicine could help adults with a condition called attention deficit hyperactivity disorder or ADHD. People with ADHD have more difficulty paying attention than other people do. They can also be more active and impulsive, have difficulty finishing what they started, and talk and fidget more than others. Stimulant medicines are used to treat the symptoms of ADHD. They help people with this condition stay calmer and focus their attention more easily. The stimulant medicine in this study, SHP465, is long acting medicine, so it needs to be taken just once a day. Researchers wanted to learn the study medicine helped the symptoms of adults with ADHD. They also wanted to learn if it caused any medical problems, also known as side effects. When was this study done? This study started in November 2015 and ended in March Who took part in this study? Who could take part in this study? People could take part in this study if they: Had ADHD Were 18 to 55 years old Were not being treated for ADHD or had problems with their current ADHD treatment Had a certain score on a questionnaire about ADHD At the beginning of the study. Could swallow a capsule 1 of 6

2 People could not take part in this study if they: Were underweight or overweight Had certain mental health problems Had certain other medical conditions For more information on who could take part, please visit the websites listed on the last page of this summary. How many people were treated in this study? There were 271 people treated in this study. There were 150 men and 121 women. They were 18 to 55 years old. Everyone in this study was treated at clinics in the United States. What happened during the study? What did researchers want to know? Researchers wanted to learn if a medicine called SHP465 could help adults with ADHD have fewer symptoms and/or less severe symptoms. Researchers measured ADHD symptoms with a questionnaire called the ADHD Rating Scale, or ADHD-RS. People can score from 0 up to 54 on this questionnaire. A higher score means ADHD symptoms are worse. Everyone in this study took the questionnaire before, during, and after treatment. Researchers also collected information on any side effects of SHP465 during and after treatment. What treatments were studied? Researchers learned about 2 study medicines. They were: SHP465 given in a capsule A placebo given in a capsule The placebo looked like SHP465, but with no medicine in it. Everyone taking part in the study took 1 capsule of study medicine every morning for 4 weeks. Everyone in the study was picked to take either SHP465 or the placebo. A computer picked people to take each medicine by chance, like pulling names out of a hat. This is also called randomization. The capsules for each medicine looked the same. No one who took the medicine knew what treatment they were taking. None of the researchers knew, either. This is called a double-blind study. 2 of 6

3 About the same number of people took each medicine. There were 3 treatments: SHP mg: 1 capsule of 12.5 milligrams (mg) SHP465 every morning for 4 weeks. SHP mg: 1 capsule of 12.5 mg SHP465 every morning for 1 week, 1 capsule of 25 mg SHP465 every morning for 1 week, and 1 capsule of 37.5 mg SHP465 every morning for 2 weeks. Placebo: 1 capsule of the placebo every morning for 4 weeks. The placebo capsule looked like the SHP465 capsule but did not have any real medicine in it. Different doses of SHP465 that people took during each week of treatment Treatment Week 1 Week 2 Week 3 Week 4 SHP mg 12.5 mg 12.5 mg 12.5 mg 12.5 mg SHP mg 12.5 mg 25.0 mg 37.5 mg 37.5 mg Placebo Placebo Placebo Placebo Placebo How was the study done? People in the study made 6 visits to the clinic, and the clinic called them 2 times. Each person was in the study for up to 9 weeks and the treatment part lasted 4 weeks. Here is what happened at each clinic visit. Visit 1 The study doctor checked if the person could take part in the study. After the visit, the clinic called to tell them which medicines to stop taking before the next visit. These medicines could affect the way the study medicine works. People who took part had their next visit after these medicines left the body completely. This could take up to 4 weeks. Visit 2 People in the study had tests before the treatment started. Study doctors measured their ADHD symptoms with the ADHD-RS questionnaire. Then, people were put in groups to receive 1 of the 3 treatments. They were given a 1-week supply of capsules of the study medicine. This was either 12.5 mg of SHP465 or the placebo. Visits 3, 4 and 5 At each visit, study doctors asked everyone taking part in the study about side effects. Doctors checked people s health, including their heart rate and blood pressure. Everyone got another 1-week supply of SHP465 capsules or placebo capsules. Some people started taking a different dose of SHP465. You can read about this above in What treatments were studied? 3 of 6

4 Visit 6 After 4 weeks of treatment, everyone taking part in the study had their ADHD symptoms tested again with the ADHD-RS questionnaire. Study doctors asked about side effects and checked people s health, including heart rate and blood pressure. This was the last study clinic visit. A week after the last clinic visit, the clinic called everyone in the study. They asked if there were any more side effects and took notes on the answers. Were there any side effects? Side effects are unwanted medical problems thought to be caused by a medicine or medical treatment. Not all of the people taking part in this study had side effects. A side effect is called serious when it is life threatening, causes lasting problems or needs hospital care. No one who took part in this study had any serious side effects. Common side effects that were not considered serious are listed in the table below. In this study, common means the side effect happened in more than 4 people from any treatment group (SHP mg, SHP mg or the placebo). This is the same as 1 out of 20 people, or 5%. Common side effects, not considered serious Placebo (out of 89 people) SHP mg (out of 92 people) SHP mg (out of 90 people) Dry mouth 3 (3.4%) 13 (14.1%) 20 (22.2%) Not feeling hungry (decreased appetite) 3 (3.4%) 17 (18.5%) 27 (30.0%) Headache 4 (4.5%) 6 (6.5%) 10 (11.1%) Trouble sleeping (insomnia) Grinding the teeth (bruxism) Problems getting to sleep (initial insomnia) Feeling irritable (irritability) 1 (1.1%) 11 (12.0%) 9 (10.0%) 0 (0.0%) 1 (1.1%) 5 (5.6%) 1 (1.1%) 4 (4.3%) 6 (6.7%) 0 (0.0%) 5 (5.4%) 2 (2.2%) 4 of 6

5 No one who took part in the study died during the study. A total of 11 people left the study early due to side effects. For more information on side effects, please visit the websites listed on the last page of this summary. What were the results? Researchers in this study wanted to learn if SHP465 could help adults with ADHD have fewer symptoms and/or less severe symptoms. They measured this by the change in ADHD-RS scores before and after the treatment. A lower score after the treatment compared to before treatment meant people had fewer symptoms and/or less severe symptoms. Researchers wanted to learn if the average ADHD-RS questionnaire scores after the treatment went down more for people who took SHP465 at 12.5 mg and 37.5 mg. This was compared to people who took the placebo. The chart below shows how the average scores went down for people who took SHP465 and for those who took the placebo. How many points did the average ADHD-RS score go down by, after treatment? Drop in ADHD-RS score after treatment Placebo (77 people) 18.1 SHP mg (78 people) 23.8 SHP mg (73 people) The score went down more for people who took SHP465, either 12.5 mg or 37.5 mg, compared to those who took the placebo. People who took SHP465 for 4 weeks had fewer symptoms and/or less severe symptoms than people who took the placebo for the same time. For more information on study results, please visit the websites listed on the last page of this summary. 5 of 6

6 How has this study helped patients and researchers? Researchers look at the results of many studies to decide which medicines work well and are safe for patients. This summary gives the results for 271 adults with ADHD in a single study. Other studies might have more patients and might give different results. Findings from this study were used to seek approval for using this treatment for people with ADHD. Are there plans for further studies? Further clinical studies with SHP465 are planned. Where can I find out more about this study? Title of this study: Protocol number: US study number: A Phase 3, Randomized, Double-blind, Multicenter, Placebo-controlled, Forced-dose Titration, Safety and Efficacy Study of SHP465 in Adults Aged Years with Attention-deficit/Hyperactivity Disorder (ADHD) SHP NCT Shire is the sponsor of this study. Shire has its headquarters in Lexington, Massachusetts, in the United States. The phone number for general information is More information about this study can be found at: This summary of the study results was written with the help of an independent non-profit organization called CISCRP (The Center for Information and Study on Clinical Research Participation). 6 of 6